Omeros Corporation

Quality Assurance Specialist/Sr. Specialist – GLP/GMP

As the Quality Assurance Specialist/Sr. Specialist, you’ll play a vital role in advancing Omeros’ portfolio of marketed and investigational products by ensuring compliance with regulatory requirements.

Good things are happening at Omeros!

Come join our Regulatory Affairs Group!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

Conducting audits of CMOs, CROs, and other service providers, writing audit reports and following up on observations/CAPAs.

Performing in-phase inspections in support of GLP studies, writing inspection reports, following up on observations/CAPAs, and preparing QA statement.

Reviewing GMP controlled documents such as master batch production records, test methods, specifications, and managing the implementation of required changes to meet GMP and internal standards.

Reviewing executed batch production records ensuring compliance with approved procedures and GMP expectations as well as communicating and resolving discrepancies with the CMO.

A demonstrated ability to build and maintain positive relationships with management, peers, subordinates, and others.

Excellent interpersonal, verbal and written communication skills.

What else do you need to know?

Occasionally, you’ll be required to travel overnight.

If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.

All interested applicants should apply at: Omeros.com, About Omeros, Careers. This will route you to our online applicant tracking system.